Salonpas Arthritis Pain

Description

Hisamitsu Salonpas Arthritis Pain Patch is a topical analgesic indicated for the temporary relief of mild to moderate pain associated with arthritis, joint pain, sprains, and strains. Each patch measures 3 15/16" x 5 1/2" (10 cm x 14 cm) and contains active ingredients menthol (3%) and methyl salicylate (10%). The product is FDA approved as a non-prescription pain-relieving patch, with its effectiveness confirmed in clinical trials. Each package contains nine patches. The packaging is not child-resistant, and it is advised to keep the product out of reach of children. Users should not apply more than one Salonpas patch at a time and should follow the directions for use, applying the patch for a duration of 8 to 12 hours.

Uses and Indications

This drug is indicated for the temporary relief of mild to moderate aches and pains associated with various conditions affecting muscles and joints. Specifically, it is effective for alleviating discomfort related to arthritis, sprains, strains, bruises, and simple backache.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults aged 18 years and older are advised to apply only one patch at a time. Prior to application, the affected area should be cleaned and dried thoroughly. The patch must be removed from its backing film and then applied directly to the skin, ensuring proper adherence. Each patch should be left in place for a duration of 8 to 12 hours. If pain persists after the initial patch application, a second patch may be applied for an additional 8 to 12 hours. It is important to note that no more than two patches should be used in a single day, and the product should not be used for more than three consecutive days. When applying a new patch, the used patch must be removed from the skin.

This product is not indicated for use in children under 18 years of age, as its efficacy has not been established in this population.

Contraindications

Use of this product is contraindicated in the following situations:

• Application on the face or on rashes is prohibited due to the potential for adverse reactions.

• The product should not be applied to wounds or damaged skin, as this may exacerbate irritation or delay healing.

• Patients with a known allergy to aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) should avoid use to prevent allergic reactions.

• Concurrent use with a heating pad is contraindicated, as this may increase the risk of skin burns or other complications.

• The product should not be used when the patient is sweating, such as during exercise or exposure to heat, as this may affect adhesion and efficacy.

• Patches from pouches that have been open for 14 days or more should not be used, as this may compromise product integrity and effectiveness.

• Use is contraindicated immediately before or after heart surgery due to potential complications related to the surgical procedure.

Warnings and Precautions

For external use only. This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may increase the risk of stomach bleeding. Although the overall risk is low, certain factors may elevate this risk, including age (60 years or older), a history of stomach ulcers or bleeding disorders, concurrent use of anticoagulants or steroid medications, use of other NSAIDs (such as aspirin, ibuprofen, or naproxen), consumption of three or more alcoholic drinks daily while using this product, and exceeding the recommended dosage or duration of use.

General precautions must be observed. This product should not be applied to the face, rashes, wounds, or damaged skin. It is contraindicated in individuals with known allergies to aspirin or other NSAIDs, and should not be used in conjunction with heating pads or during periods of excessive sweating (e.g., from exercise or heat). Additionally, it should not be used immediately before or after heart surgery. Healthcare professionals should advise patients to consult a physician prior to use if they have allergies to topical products, if the stomach bleeding warning is applicable, if they are taking diuretics, or if they have a history of high blood pressure, heart disease, or kidney disease.

While using this product, it is essential to wash hands thoroughly after applying or removing the patch and to avoid contact with the eyes. In the event of eye contact, the affected area should be rinsed thoroughly with water. Patients should be informed that the risk of heart attack or stroke may increase if the product is used in excess of the recommended dosage or duration.

Emergency medical assistance should be sought immediately if the product is ingested, or if there are any concerns regarding potential poisoning, by contacting a Poison Control Center.

Patients should discontinue use and consult a healthcare provider if they experience worsening stomach pain or upset, faintness, vomiting of blood, or the presence of bloody or black stools, as these may indicate stomach bleeding. Additionally, they should seek medical advice if a rash, itching, or skin irritation develops, if their condition worsens, if symptoms persist beyond three days, or if symptoms resolve and then recur within a few days.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions. This product is intended for external use only. It contains a nonsteroidal anti-inflammatory drug (NSAID), which may increase the risk of stomach bleeding. Although the overall chance of experiencing stomach bleeding is small, certain factors may elevate this risk, including being age 60 or older, having a history of stomach ulcers or bleeding problems, concurrent use of blood thinners (anticoagulants) or steroid medications, taking other NSAIDs (such as aspirin, ibuprofen, or naproxen), consuming three or more alcoholic drinks daily while using this product, or exceeding the recommended dosage or duration of use.

Patients should not use this product on the face, rashes, wounds, or damaged skin, and it is contraindicated for individuals allergic to aspirin or other NSAIDs. Additionally, it should not be used in conjunction with heating pads, during sweating (such as from exercise or heat), on any patch from a pouch that has been open for 14 or more days, or immediately before or after heart surgery.

Before using this product, patients should consult a healthcare professional if they have allergies to topical products, if the stomach bleeding warning applies to them, if they are taking diuretics, or if they have high blood pressure, heart disease, or kidney disease.

While using this product, patients are advised to wash their hands after applying or removing the patch and to avoid contact with the eyes. In the event of eye contact, it is important to rinse thoroughly with water. There is an increased risk of heart attack or stroke if the product is used in excess of the directed dosage or for longer than recommended.

Patients should discontinue use and seek medical advice if they experience worsening stomach pain or upset, faintness, vomiting blood, or bloody or black stools, as these may indicate stomach bleeding. Other signs to watch for include the development of a rash, itching, or skin irritation, worsening of the condition, persistence of symptoms beyond three days, or recurrence of symptoms after they have cleared.

For pregnant or breastfeeding patients, it is crucial to consult a healthcare professional before use. The use of methyl salicylate is particularly discouraged after 20 weeks of pregnancy unless specifically directed by a doctor, as it may pose risks to the unborn child or complications during delivery.

This product should be kept out of reach of children. In the event of ingestion, immediate medical assistance or contact with a Poison Control Center is necessary. The packaging is not child-resistant, and used patches should be disposed of properly by folding the sticky ends together.

Drug Interactions

The product contains a nonsteroidal anti-inflammatory drug (NSAID), which may increase the risk of gastrointestinal bleeding, particularly in patients concurrently using anticoagulants or corticosteroids. Caution is advised when prescribing this product alongside these medications due to the heightened risk of adverse effects.

Co-administration with other NSAIDs, including but not limited to aspirin, ibuprofen, and naproxen, is contraindicated. The use of multiple NSAIDs can exacerbate the risk of gastrointestinal complications and should be avoided.

Patients taking diuretics should consult a healthcare professional prior to using this product, as there may be potential interactions that necessitate monitoring or dosage adjustments.

Additionally, the risk of cardiovascular events, such as heart attack or stroke, may be elevated with the use of this product, particularly if it is used in excess of the recommended dosage or for an extended duration. It is essential to adhere to the prescribed guidelines to mitigate these risks.

Packaging & NDC

Below are the non-prescription pack sizes of Salonpas Arthritis Pain (menthol, methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Children under 18 years of age should not use this product, as it has not been demonstrated to be effective in this population. Additionally, it is important to keep the product out of reach of children due to safety concerns. The packaging is not child-resistant, which further emphasizes the need for careful storage to prevent accidental ingestion.

Geriatric Use

Elderly patients may be at an increased risk for stomach bleeding when using this product, which contains a nonsteroidal anti-inflammatory drug (NSAID). Although the overall chance of experiencing such adverse effects is small, it is notably higher in patients aged 60 years and older.

Healthcare providers should exercise caution when prescribing this medication to geriatric patients. Close monitoring for signs of gastrointestinal bleeding is recommended, particularly in this age group. Additionally, consideration should be given to the potential need for dosage adjustments or alternative therapies that may pose a lower risk of gastrointestinal complications in elderly patients.

Pregnancy

Pregnant patients should consult a healthcare professional before using this medication, particularly if they are in the later stages of pregnancy or breastfeeding. Methyl salicylate is contraindicated for use at 20 weeks of gestation or later unless specifically directed by a physician, as it may pose risks to the developing fetus and could lead to complications during delivery. It is essential for women of childbearing potential to weigh the benefits and risks of treatment with their healthcare provider to ensure the safety of both the mother and the unborn child.

Lactation

Lactating mothers are advised to consult a healthcare professional before using this medication while breastfeeding. It is particularly important to avoid the use of methyl salicylate at 20 weeks of pregnancy or later unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering its use in lactating individuals.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have a history of high blood pressure, heart disease, or kidney disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of renal impairment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the prescribing information.

Overdosage

In the event of overdosage, immediate medical assistance is crucial. If the product is ingested, healthcare professionals should be contacted without delay, or the local Poison Control Center should be notified for guidance.

It is important to note that the packaging of this product is not child-resistant, which may increase the risk of accidental ingestion, particularly in pediatric populations. Therefore, proper disposal of used patches is essential to prevent accidental exposure. Used patches should be folded with the sticky ends together before disposal to minimize the risk of accidental contact.

Healthcare providers are advised to monitor for any symptoms associated with overdosage and to implement appropriate management procedures as necessary.

Nonclinical Toxicology

It is especially important not to use methyl salicylate at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor, as it may cause problems in the unborn child or complications during delivery. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the text.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Reports of rash, itching, and skin irritation have been documented. Additionally, there have been observations of stomach bleeding, particularly in patients who are older, have a history of stomach ulcers or bleeding problems, or are concurrently using anticoagulants or other nonsteroidal anti-inflammatory drugs (NSAIDs).

Cases of fainting, vomiting blood, and the presence of bloody or black stools have also been reported, which may indicate stomach bleeding. Furthermore, it has been noted that some individuals may not experience pain relief until several hours after applying the patch.

Patient Counseling

Healthcare providers should advise patients that if the product is placed in the mouth, they must seek medical help or contact a Poison Control Center immediately. It is important to inform patients that the packaging is not child-resistant, which may pose a risk to young children. Additionally, healthcare providers should instruct patients on the proper disposal of used patches by folding the sticky ends together before discarding them to prevent accidental exposure.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It is essential to store the product at a temperature range of 20 to 25 degrees Celsius (68 to 77 degrees Fahrenheit). Care should be taken to avoid exposure to direct sunlight, as this may compromise the integrity of the product. Additionally, it is crucial to protect the product from excessive moisture to ensure its stability and efficacy.

Additional Clinical Information

The route of administration for the medication is topical, percutaneous, and transdermal. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is particularly crucial to avoid the use of methyl salicylate at 20 weeks of pregnancy or later unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery.

No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Salonpas Arthritis Pain, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)